FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUAL COMPARTMENT TPN BAG 3 LITER
K Number: K911567
·
Decision Aug 2, 1991
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
3
Review Days
115
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Basic Information
- Device Name
- DUAL COMPARTMENT TPN BAG 3 LITER
- K Number
- K911567
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Stedim, Inc.
- Date Received
- April 9, 1991
- Decision Date
- August 2, 1991
- Product Code
- KPE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPE | Container, I.V. | FDA class 2 | General Hospital |
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